French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

ClinicalTrials.gov Identifier:

NCT00928187

First Posted: June 25, 2009

Last Update Posted: February 27, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Collaborators:

Gilead Sciences

Janssen Pharmaceutica

Information provided by (Responsible Party):

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Since the first line antiretroviral (ARV) treatment is now largely accessible in the Sub-Saharian Africa countries, documentation of virological failure, drug resistance patterns and second line treatment evaluation are still to be consolidated in settings where viral load monitoring is not available and non-B HIV subtype is predominant.

This trial aims at evaluating the efficacy and tolerance of 3 different second line treatment strategies: two recommended by WHO combine two non-nucleoside reverse transcriptase inhibitor associated with a ritonavir boosted protease inhibitor (emtricitabine-tenofovir-lopinavir/ritonavir and abacavir-didanosine-lopinavir/ritonavir); the third strategy combines emtricitabine-tenofovir-darunavir/ritonavir and is not yet evaluated in Sub-Saharian Africa. Darunavir has a potentially superior antiviral efficacy, a better tolerance and its single daily administration may facilitate treatment adherence.

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patient over the age of 18 years at pre-inclusion and monitored under outpatient conditions

Patient agrees not to take any concomitant medication during the trial without informing the investigator

Informed consent signed no later than D-15

For women in childbearing age: negative pregnancy test at inclusion, with no plan of pregnancy in the coming 12 months and agreeing to use mechanical contraception (with or without hormonal contraception) during the study

Exclusion Criteria:

Infection with HIV-2 or HIV-1 groups O or N or HIV1+2

Deficiency of the patient, making it difficult, if not impossible, for him/her to take part in the trial or understand the information provided to him/her

Participation in any other clinical trial

Presence of an uncontrolled, ongoing opportunistic infection or of any severe or progressive disease

First-line treatment with a protease inhibitor, abacavir, tenofovir or ddI

Ongoing treatment with rifampicin

Severe hepatic insufficiency (TP < 50%)

ALAT > 3 x ULN

Creatinine clearance calculated by Cockcroft formula < 50 ml/min

Hb ≤ 8 g/dl

Platelets < 50,000 cells/mm3

Neutrophiles < 500 cells/ mm3

Use of drugs prohibited in the context of this trial (drugs contraindicated by the SCP of the trial drugs) - in the event of tuberculosis or malaria during the trial, a list of authorized medicines and, if necessary, a dose adjustment of the antiretroviral medication will be provided

Pregnancy or lactation

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928187

Locations

Burkina Faso

Day Hospital, CHU Sanou Souro

Bobo Dioulasso, Burkina Faso

Cameroon

Day Hospital, Central Hospital

Yaounde, Cameroon

Senegal

Clinical Research and Training Center, Fann Hospital

Dakar, Senegal

Sponsors and Collaborators

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Gilead Sciences

Janssen Pharmaceutica

Investigators

Principal Investigator:

Sinata Koulla Shiro, PhD

Infectious diseases department, Central Hospital, Yaounde, Cameroon

Principal Investigator:

Papa Salif Sow, PhD

Infectious Diseases Department, Fann Hospital, Dakar, Senegal

Principal Investigator:

Adrien Sawadogo, MD

Day Hospital, CHU Sanou Souro, Bobo Dioulasso, Burkina Faso

More Information

Responsible Party:

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)